Introducer seal assembly with low profile gimbal seal

ABSTRACT

A surgical seal assembly for use with a surgical access device includes a seal housing defining a central longitudinal axis and having a longitudinal passage dimensioned to permit passage of a surgical instrument through the seal housing, a gimbal mount disposed within the seal housing and having a gimbal seal member defining an aperture for substantial sealed reception of the surgical instrument, and an interface seal disposed within the seal housing. The gimbal mount is adapted for angular movement relative to the central longitudinal axis upon angulation of the surgical instrument whereby the gimbal seal member substantially maintains the sealed reception of the surgical instrument. The interface seal includes an interface seal member extending at least along the longitudinal axis and being in substantial contacting sealing relation with the gimbal mount. The interface seal member is adapted to maintain the sealing relation with the gimbal mount upon angular movement thereof.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 11/098,966,filed Apr. 5, 2005, now U.S. Pat. No. 7,931,624, theentire contents of which are hereby incorporated by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to a seal system adapted to permit theintroduction of surgical instrumentation into a patient's body. Inparticular, the present disclosure relates to a seal system for use withan introducer or access device which is intended for insertion into apatient's body, and to receive an instrument in sealing engagementtherewith.

2. Description of the Related Art

Minimally invasive and laparoscopic procedures generally require thatany instrumentation inserted into the body is sealed, i.e., provisionsmust be made to ensure that gases and/or fluids do not enter or exit thebody through an endoscopic incision, such as, for example in surgicalprocedures where the surgical region is insufflated. For suchprocedures, the introduction of a tube into anatomical cavities, such asthe peritoneal cavity, is usually accomplished by use of a systemincorporating a trocar and cannula assembly. Since the cannula is indirect communication with the interior of the peritoneal cavity,insertion of the cannula into an opening in the patient's body to reachthe inner abdominal cavity should be adapted to maintain a fluid tightinterface between the abdominal cavity and the outside atmosphere. Inview of the need to maintain the atmospheric integrity of the inner areaof the cavity, a seal assembly for a cannula, which permits introductionof a wide range of surgical instrumentation and maintains theatmospheric integrity of the inner area of the cavity, is desirable. Inthis regard, there have been a number of attempts in the prior art toachieve such sealing requirements. A difficulty encountered withconventional seal assemblies, however, is the inability of accommodatingthe wide range of sizes of instrumentation. In addition, angulationand/or manipulation of instrumentation within the cannula often presentdifficulties with respect to maintaining seal integrity.

SUMMARY

Accordingly, the present disclosure provides a seal assembly which willallow a surgeon to efficaciously utilize instruments of varying diameterin a surgical procedure. This seal assembly obviates the need formultiple adapters to accommodate instruments of varying diameter byproviding an apertured resilient seal member which is mounted in agimbal-like assembly. In one preferred embodiment, a surgical sealassembly for use with a surgical access device, includes a seal housingdefining a central longitudinal axis and having a longitudinal passagedimensioned to permit passage of a surgical instrument through the sealhousing, a gimbal mount disposed within the seal housing and having agimbal seal member defining an aperture for substantial sealed receptionof the surgical instrument, and an interface seal disposed within theseal housing. The gimbal mount is adapted for angular movement relativeto the central longitudinal axis upon angulation of the surgicalinstrument whereby the gimbal seal member substantially maintains thesealed reception of the surgical instrument. The interface seal includesa resilient interface seal member extending at least along thelongitudinal axis and being in substantial contacting sealing relationwith the gimbal mount. The interface seal member is adapted to maintainthe sealing relation with the gimbal mount upon angular movementthereof.

One preferred interface seal includes a relatively rigid interface mountwhereby the interface seal member is mounted to the interface mount. Theinterface seal may include an annular gasket seal member mounted to theinterface mount and positioned to contact an internal surface of theseal housing in substantial sealing relation therewith to form asubstantial seal within the seal housing. The interface seal member andthe gasket seal member may be monolithically formed. The gasket sealmember is mounted adjacent a proximal side of the interface mount andthe interface seal member is mounted adjacent a distal side of theinterface mount.

The seal housing includes an interior wall portion at least partiallydefining the longitudinal passage. The interior wall portion is disposedin oblique relation relative to the longitudinal axis to taper radiallyinwardly along the longitudinal axis to facilitate reception of thesurgical instrument. The interior wall portion is adjacent a proximalend of the seal housing. The interior wall portion permits the surgeonto introduce an instrument without concern that the instrument be insubstantial alignment with the longitudinal axis of the seal housing.

The preferred seal housing defines a reduced profile having a heightranging from about 0.25 inches to about 1.0 inches, preferably, 0.65inches.

The gimbal seal member may include a resilient member and a protectivelayer juxtaposed relative to the resilient member. The protective layerof the gimbal seal member extends at least partially within the apertureto protect portions of the seal member defining the aperture duringpassage of the surgical instrument. The protective layer may include afabric material.

In another preferred embodiment, the surgical seal assembly for use witha surgical access device includes a low profile seal housing defining acentral longitudinal axis and having an internal wall defining alongitudinal passage dimensioned to permit passage of a surgicalinstrument through the seal housing, a gimbal mount disposed within theseal housing and having a gimbal seal member defining an aperture forsubstantial sealed reception of the surgical instrument, and aninterface seal disposed within the seal housing. The internal wall ofthe seal housing defines a tapered internal wall portion dimensioned toreceive the surgical instrument when inserted within the longitudinalpassage in angulated relation thereto. The interface seal includes anannular interface seal mount and an interface seal member mounted to theinterface seal mount. The interface seal member extends at leastradially inwardly relative to the longitudinal axis to contact thegimbal mount and form a substantial seal therewith. The interface sealmember is adapted to maintain the sealing relation with the gimbal mountupon angular movement thereof. The gimbal mount is adapted for angularmovement relative to the central longitudinal axis upon angulation ofthe surgical instrument whereby the gimbal seal member substantiallymaintains the sealed reception of the surgical instrument. The preferredseal housing defines a height ranging from about 0.25 inches to about1.0 inches.

The preferred seal housing defines an arcuate channel portion for atleast partially accommodating the gimbal mount. The gimbal mount isadapted to traverse the arcuate channel portion. The interface sealmember may be dimensioned to extend along the central longitudinal axisof the seal housing. The interface seal may include an annular gasketseal member mounted to the interface mount and positioned to contact aninternal surface of the seal housing in substantial sealing relationtherewith to form a substantial seal within the seal housing. The sealhousing is adapted to be detachably mounted to a cannula assembly.

The movement of the gimbal mount relative to the housing which isaccommodated by the gimbal-like structure also facilitates sealmaintenance once an instrument is being used within the body cavity. Inparticular, as an instrument is manipulated, the gimbal seal memberrepositions itself through movement of the gimbal mount relative to theseal housing, thereby ensuring that the gimbal seal member maintains afluid-tight seal around the instrument shaft.

Other features and advantages of the present disclosure will becomeapparent from the following detailed description, taken in conjunctionwith the accompanying drawings, which illustrate, by way of example, theprincipals of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing features of the present disclosure will become morereadily apparent and will be better understood by referring to thefollowing detailed description of preferred embodiments, which aredescribed hereinbelow with reference to the drawings wherein:

FIGS. 1-2 are perspective views of a cannula assembly and a sealassembly in accordance with the principles of the present disclosure;

FIG. 3 is a perspective view with parts separated of the cannula andseal assemblies of FIG. 1 in accordance with the embodiment of FIGS.1-2;

FIG. 4 is a side cross-sectional view of the cannula and seal assembliesin accordance with the embodiment of FIGS. 1-3;

FIG. 5A is a perspective view of the interface seal of the seal assemblyin accordance with the embodiment of FIGS. 1-4;

FIG. 5B is a cross-sectional view of the interface seal taken alongsection lines 5B-5B of FIG. 5A illustrating the interface seal mount andthe interface seal member of the seal assembly in accordance with theembodiment of FIGS. 1-5A;

FIG. 5C is a perspective view of the interface seal mount of theinterface seal in accordance with the embodiment of FIGS. 1-5B;

FIGS. 6-7 are top and bottom perspective views of the gimbal mount ofthe seal assembly in accordance with the embodiment of FIGS. 1-5C;

FIGS. 8-9 are cross-sectional views of the gimbal mount in accordancewith the embodiment of FIGS. 1-7;

FIG. 10 is a perspective view illustrating the components of the gimbalmount in accordance with the embodiment of FIGS. 1-9;

FIGS. 11-13 are perspective views illustrating the range of movement ofthe gimbal mount within the seal housing in accordance with theembodiment of FIGS. 1-10;

FIG. 14 is a view illustrating the cannula assembly and seal assemblyaccessing an internal cavity with an instrument introduced therein inaccordance with the embodiment of FIGS. 1-13; and

FIG. 15 is a side cross-sectional view of the cannula and sealassemblies illustrating a range of movement of the surgical instrumentin accordance with the embodiment of FIGS. 1-14.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The seal assembly of the present disclosure, either alone or incombination with a seal system internal to a cannula assembly, providesa substantial seal between a body cavity of a patient and the outsideatmosphere before, during and after insertion of an instrument throughthe cannula assembly. Moreover, the seal assembly of the presentinvention is capable of accommodating instruments of varying diameters,e.g., from 5 mm to 15 mm, by providing a gas tight seal with eachinstrument when inserted. The flexibility of the present seal assemblygreatly facilitates endoscopic surgery where a variety of instrumentshaving differing diameters are often needed during a single surgicalprocedure.

The seal assembly contemplates the introduction and manipulation ofvarious types of instrumentation adapted for insertion through a trocarand/or cannula assembly while maintaining a fluid tight interface aboutthe instrumentation to preserve the atmospheric integrity of a surgicalprocedure from gas and/or fluid leakage. Specifically, the seal assemblyaccommodates angular manipulation of the surgical instrument relative tothe seal housing axis. This feature of the present disclosure desirablyminimizes the entry and exit of gases and/or fluids to/from the bodycavity. Examples of instrumentation include clip appliers, graspers,dissectors, retractors, staplers, laser probes, photographic devices,endoscopes and laparoscopes, tubes, and the like. Such instruments willbe collectively referred to herein as “instruments or instrumentation”.

By virtue of its features, the seal assembly further defines asubstantially reduced profile when assembled together and mounted to acannula assembly. This reduced profile advantageously increases theworking length of instruments introduced into the body cavity throughthe cannula assembly. In addition, the reduced profile permits enhancedangulation of a surgical instrument relative to the seal housing axis.

In the following description, as is traditional the term “proximal”refers to the portion of the instrument closest to the operator whilethe term “distal” refers to the portion of the instrument remote fromthe operator.

Referring now to the drawings, in which like reference numerals identifyidentical or substantially similar parts throughout the several views,FIGS. 1-2 illustrate the seal assembly 100 of the present disclosuremounted to cannula assembly 200. Cannula assembly 200 may be anyconventional cannula suitable for the intended purpose of accessing abody cavity and permit introduction of instruments therethrough. Cannulaassembly 200 is particularly adapted for use in laparoscopic surgerywhere the peritoneal cavity is insufflated with a suitable gas, e.g.,CO₂, to raise the cavity wall from the internal organs therein. Cannulaassembly 200 is typically used with an obturator assembly (not shown)which is a sharp pointed instrument positionable within the passagewayof the cannula assembly 200. The obturator assembly is utilized topenetrate the abdominal wall and then subsequently removed from thecannula assembly 200 to permit introduction of the surgicalinstrumentation utilized to perform the procedure.

With reference to FIGS. 1-4, cannula assembly 200 includes cannulasleeve 202 and cannula housing 204 mounted to an end of the sleeve 202.Any means for mounting cannula sleeve 202 to cannula housing 204 areenvisioned including threaded arrangements, bayonet coupling, snap-fitarrangements, adhesives, etc. Cannula sleeve 2-2 and cannula housing 204may be integrally formed. Cannula sleeve 202 defines a longitudinal axis“a” extending along the length of sleeve 202. Sleeve 202 further definesan internal longitudinal passage 206 dimensioned to permit passage ofsurgical instrumentation. Sleeve 202 defines collar 208 which is mountedto cannula housing 202 and an inner tapered wall 210 adjacent the collar208. The sloped configuration of tapered wall 210 may assist in guidingthe inserted instrument into longitudinal passage 206. Adjacent thedistal end of cannula sleeve 202 is aperture 212 which extends throughthe wall of the sleeve 202. Aperture 212 permits passage of insufflationgases through cannula sleeve 202 during the surgical procedure. Sleeve202 may be formed of stainless steel or other rigid materials such as apolymeric material or the like. Sleeve 202 may be clear or opaque. Thediameter of sleeve 202 may vary, but, typically ranges from about 10 mmto about 15 mm for use with the seal assembly 100 of the presentdisclosure.

Cannula housing 204 includes port opening 214 and luer fitting 216positioned within the port opening 214. Luer fitting 216 is adapted forconnection to a supply of insufflation gaseous is conventional in theart and incorporates valve 218 to selectively open and close the passageof the luer fitting 216. Cannula housing 204 further includes duckbillor zero closure valve 220 which tapers distally and inwardly to a sealedconfiguration. Closure valve 220 defines slit 222 which opens to permitpassage of the surgical instrumentation and closes in the absence of theinstrumentation. Closure valve 220 is preferably adapted to close uponexposure to the forces exerted by the insufflation gases in the internalcavity. Other zero closure valves are also contemplated including singleor multiple slit valve arrangements, trumpet valves, flapper valves,etc. Closure valve 220 rests upon internal shelf 224 of cannula housing204 when assembled.

Cannula housing 204 includes at least one locking recess 226 preferablytwo recesses arranged in diametrical opposed relation. Locking recesses226 serve to releasably secure seal assembly 100 to cannula assembly200.

With continued reference to FIGS. 1-4, seal assembly 100 will bediscussed in detail. Seal assembly 100 may be a separate component fromcannula assembly 200 and, accordingly, adapted for releasable connectionto the cannula assembly 200. Alternatively, seal assembly 100 may beincorporated as part of cannula assembly 200. Seal assembly 100 includesa seal housing, generally identified as reference numeral 102, andgimbal mount 104 which is disposed within the seal housing 102. Sealhousing 102 houses the sealing components of the assembly and definesthe outer valve or seal body of the seal assembly 100. Seal housing 102defines central seal housing axis “b” which is preferably parallel tothe axis “a” of cannula sleeve 202 and, more specifically, coincidentwith the axis “a” of the cannula sleeve 202. Seal housing 102incorporates three housing components, namely, first, second and thirdhousing components 106, 108, 110, respectively, which, when assembledtogether, form the seal housing 102. Assembly of housing components 106,108, 110 may be affected by any of the aforementioned connection meansdiscussed with respect to cannula housing 204.

First housing component 106 defines inner guide wall 112 and outer wall114 disposed radially outwardly of the inner guide wall 112. Inner guidewall 112 defines central passage 116 which is dimensioned to receive asurgical instrument and laterally confine the instrument within sealhousing 102. As best shown in FIG. 4, inner guide wall 112 definessloped or tapered portion 118 adjacent its proximal end. Sloped portion118 is obliquely arranged relative to seal housing axis “b” and extendsradially inwardly relative to the seal housing axis “b” in the distaldirection. Sloped portion 118 assists in guiding the inserted instrumentinto central passage 116, particularly, when the instrument isnon-aligned or off-axis relative to the seal housing axis “b”, orintroduced at an angle relative to the seal housing axis “b”. Slopedportion 118 provides more flexibility to the surgeon by removing thenecessity that the instrument be substantially aligned with the sealhousing axis “b” upon insertion. Inner guide wall 112 is generallycylindrical in configuration and terminates in a distal arcuate orrounded surface 120.

Second housing component 108 includes transverse wall 122, innercylindrical wall 124 depending in a proximal direction outwardly fromthe transverse wall 120 and outer wall 126 depending in a distaldirection outwardly from the transverse wall 120. Inner cylindrical wall124 is dimensioned to mate with outer wall 114 of first housingcomponent 106, i.e., in a manner to be positioned within the interior ofthe outer wall 114 in frictional relation therewith. In the alternative,outer wall 114 of first housing component 106 may be adhered to innercylindrical wall 124 of second housing component 108. Outer wall 126defines scalloped outer surface 126 a which is dimensioned for grippingengagement by the user. Extending contiguously from inner cylindricalwall 124 in the distal direction is an arcuate or cup shaped gimbal wallsupport 124 s which supports gimbal mount 104. Transverse wall 120further includes intermediate wall 128 of cylindrical configuration,which is disposed between outer wall 126 and gimbal wall support 124 s.

Referring now to FIGS. 3-4, in conjunction with FIGS. 5A-5C, sealassembly 100 further includes interface seal 130 mounted adjacent gimbalmount 104. Interface seal 130 functions in minimizing the loss ofinsufflation gases through seal assembly 100. Interface seal 130includes interface seal mount 132 and flexible interface seal member 134secured to the seal mount 132. Seal mount 132 is preferably annular inconfiguration and is fabricated from a relatively rigid material such asa polymeric material or stainless steel. Interface seal member 134 ispreferably fabricated from an elastomeric material having qualities toengage seal mount 104 in substantial sealed relation therewith.Interface seal member 134 defines central aperture 136 which receivesthe forward or distal surface of gimbal mount 104. Interface seal member134 preferably extends radially inwardly and longitudinally relative toseal housing axis “b” when assembled within seal housing 102. Thisconfiguration increases the amount of surface area of interface sealmember 134 engaging the outer surface of gimbal mount 104 therebyfacilitating the formation and maintenance of a seal about the gimbalmount during manipulation of the instrument. Interface seal 130 furtherincludes gasket seal 136 mounted adjacent the proximal side of interfaceseal mount 132. Gasket seal 136 is in contact with the forward or distalend of intermediate wall 128 of second housing component 108 and servesto form a seal with the intermediate wall to substantially minimizepassage of fluids through seal housing 102.

Interface seal member 134 and gasket seal 136 are preferablymonolithically formed of the desired elastomeric material. In onepreferred arrangement, interface seal 130 is manufactured via a moldingprocess. In this arrangement, interface seal mount 132 may include aplurality of apertures 138. During molding of interface seal 130,apertures 138 permit the elastomeric material to communicate between theproximal and distal sides of interface seal mount 132 to monolithicallyform interface seal member 134 and gasket seal 136. Alternatively,gasket seal 136 may be a separate component from interface seal member134 and may be secured to the seal mount 132 by conventional means.

With particular reference to FIG. 4, gimbal mount 104 is accommodatedwithin an annular space 140 defined between inner and outer walls 112,114 of first housing component 106. Gimbal mount 104 is mounted in amanner which permits angulation and/or rotational movement of the gimbalmount 104 relative to, or about, seal housing axis “b”. Specifically,gimbal mount 104 is free to angulate relative to seal housing axis “b”through a range of motion defined within the confines of annular space140. The range of movement of gimbal mount 104 will be discussed ingreater detail hereinbelow. Interface seal 130 is adapted to maintain asealing relation with gimbal mount 104 upon angular movement thereof.

Referring now to FIGS. 6-10, in conjunction with FIG. 4, the componentsof gimbal mount 104 will be discussed in further detail. Gimbal mount104 includes first and second gimbal housings 142, 144 and resilientseal member 146 which is mounted between the housings 142, 144. In apreferred arrangement, first and second gimbal housings 142, 144 andseal member 146 each define a general hemispherical configuration asshown. First gimbal housing 142 is preferably seated within secondgimbal housing 144 and secured to the second gimbal housing 144 througha snap fit connection, welding, adhesives, or the like. Preferably,first gimbal housing 142 includes a plurality of mounting legs 148radially spaced about the outer periphery of the housing component 134.Legs 148 define locking surfaces 150 which extend in general transverserelation to the axis “b” of seal assembly 200. Similarly, second gimbalhousing 144 includes a plurality of corresponding locking detents 152spaced about the interior of the housing 144. Upon insertion of firstgimbal housing 142 within second gimbal housing 144, mounting legs 148slide along locking detents 152 whereby upon clearing the detents 152,locking surfaces 150 of the mounting legs 148 securely engage thelocking detents 152 to fix first gimbal housing 142 within second gimbalhousing 144 and secure resilient seal member 146 between the componentsin sandwiched relation. As appreciated, first gimbal housing 142 isdesirably sufficiently resilient to deflect upon insertion to permitmounting legs 148 to clear locking detents 152 and return to theirinitial position to engage the detents 152.

As mentioned hereinabove, seal member 146 of gimbal mount 104 isinterposed between first and second gimbal housings 142, 144. Sealmember 146 preferably comprises a resilient center material (e.g.,polyisoprene or natural rubber) with first and second layers of fabric154, 156 at the respective proximal and distal surfaces of the resilientmaterial and impregnated with the resilient material. The fabric may beof any suitable fabric for example, a SPANDEX material containing about20% LYCRA and about 80% NYLON available from Milliken. A suitable sealmember or seal type is disclosed in commonly assigned U.S. patentapplication Ser. No. 09/449,368, filed Nov. 24, 1999, the contents ofwhich are hereby incorporated herein by reference. Seal member 146defines central aperture 158 for sealed reception of a surgicalinstrument. In a preferred arrangement, first layer 154 is arranged toextend or overlap into aperture 158. In this manner, the fabric ispositioned to engage the surgical instrument upon passage throughaperture 158 of seal member 146 thereby protecting the resilientmaterial defining the aperture. This advantageously minimizes thepotential of piercing, penetrating or tearing of the resilient materialby the instrument. Alternatively, an additional layer of fabric on theproximal surface of seal member 146 may be superposed and arranged todrape within aperture 158. Seal member 146 preferably includes anannular depression 160 on its distal surface, i.e., within second layer156 of fabric. Depression 160 receives ledge 162 of second gimbalhousing 144 to facilitate fixation of seal member 146 between first andsecond gimbal housings 142, 144.

Although seal member 146 is disclosed as an impregnated fabricarrangement, it is appreciated that other seal types may be used andstill achieve the objectives of the present disclosure. Further, FIG. 8illustrates annular depressions 164, 166 which have been pressed by amolding tool into layer 160. One or more similar depressions may bepressed into layer 160 to assist positioning of fabric duringmanufacture of seal member 146.

Seal assembly 100 defines a profile or height which is substantiallyreduced when compared to conventional cannula seal assemblies. In onepreferred embodiment, the overall height of seal assembly 100 rangesfrom about 0.25 inches to about 1.0 inches, preferably, about 0.65inches. The reduced height provides more operating space above thepatient, which is significant, i.e., positioned in the abdomen to accessthe underlying cavity.

With reference now to FIGS. 11-13, in conjunction with FIG. 4, gimbalmount 104 moves within the annular space 140 defined between inner andouter walls 112, 114 to permit angulation of the instrument relative tothe seal housing axis “b” and/or rotation about the axis “b” (shown bydirectional arrow “d”) while still maintaining a seal thereabout. Duringangulation of the instrument, the axis “c” of the aperture 158 of sealmember 146 intersects the axis “b” of the seal assembly 100. Duringangulation, gimbal mount 104 is supported between inner wall 112 andgimbal wall support 124 s of seal housing 102. The arcuate inner surfaceof first gimbal housing 142 rides along distal arcuate surface 120 ofinner wall 112 in contacting relation therewith to permit gimbal mount104 to swivel within seal housing 102. Interface seal member 134 ofinterface seal 130 permits angular movement of gimbal mount 104 whilemaintaining the substantial sealing relation with the outer surface ofsecond gimbal housing 144. Lubricant may be provided on the appropriatesurfaces to facilitate angulation. In a preferred arrangement, gimbalmount 104 may angulate through an angle inclusive of about 30°, morepreferably about 22.5° relative to seal housing axis “b”.

Seal assembly 100 may be associated with, or joined to, cannula assembly200 in a variety of ways. In a preferred embodiment, seal housing 102 ofseal assembly 100 and cannula housing 204 of cannula assembly 200 areadapted to detachably engage each other, e.g., through a bayonet lock,threaded connection, or like mechanical means. In one preferredembodiment, second housing component 108 of seal housing 102 includes aplurality of ribs 170 depending radially inwardly from outer wall 24(FIG. 3). Ribs 170 are received within locking recesses 224 of cannulahousing 204, and seal assembly 100 is rotated to secure the ribs 170beneath the outer wall 226 of cannula housing 204. Other means ofjoining seal assembly 100 to cannula assembly 200 will be readilyapparent to one of ordinary skill in the art.

Referring now to FIG. 15, use of the seal assembly 100 and cannulaassembly 200 in connection with introduction of a surgical instrumentwill be discussed. Seal assembly 100 is mounted to cannula assembly 200which may or may not be previously introduced into an insufflatedabdominal cavity. An instrument “i” is inserted into seal assembly 100through passage 116 of inner cylindrical guide wall 112 in seal housing102. If the axis of the instrument is not perfectly aligned with theaxis “a” of cannula assembly 200 or axis “b” of seal assembly 100, thenthe surgical instrument will contact sloped portion 118 of inner guidewall 112 and/or the inner surface of the seal member 146. Sloped portion118 guides the instrument into seal housing 102. Contact with sealmember 142 can cause some deformation of the seal member 142. Theinstrument “i” slides along the surface of the gimbal mount 104 and/orthe seal member 142 to the aperture 154. The inner seal portionsdefining aperture 154 stretch to accommodate the instrument diameter, asnecessary. The instrument “i” is advanced through aperture 158 of sealmember 146 whereby portions of the seal member 146 defining the aperture158 engage the instrument “i” in sealed relation therewith. Theinstrument “i” passes further distally into the cannula housing 204passing through duckbill valve 216 and cannula sleeve 202 into the bodycavity. The instrument “i” may be manipulated within seal housing 102and cannula housing 204. Once the instrument “i” is disposed within theaperture 154, and the friction at the interface seal member 134, gimbalmount 104 and sloped portion 118 is overcome, gimbal mount 104, swivelswith respect to seal housing 102 as the instrument is manipulated.Gimbal mount 104 is free to swivel relative to housing 102, whileallowing seal member 142 to maintain sealing engagement with theinstrument “i” passed therethrough, as well as maintaining the sealaround the gimbal mount 104. Preferably, the seal member 142 includesresilient material and fabric material which resists deformation of theaperture 154, as well as tearing of the seal member 142. As discussed,the instrument “i” may be rotated about seal housing axis “b” or pivotedrelative to the axis “b” as desired via gimbal mount 104 to perform thesurgical procedure. During these manipulations, interface seal member134 of interface seal 130 maintains a sealing relation with gimbal mount104.

While the invention has been particularly shown, and described withreference to the preferred embodiments, it will be understood by thoseskilled in the art that various modifications and changes in form anddetail may be made therein without departing from the scope and spiritof the invention. Accordingly, modifications such as those suggestedabove, but not limited thereto, are to be considered within the scope ofthe invention.

The invention claimed is:
 1. A surgical access device, which comprises:a housing defining a central longitudinal axis and having a longitudinalpassage to permit passage of a surgical object through the seal housing;a seal mount mounted to the seal housing, the seal mount adapted forangular movement relative to the central longitudinal axis and havinginners surface portions dimensioned for substantial sealed reception ofthe surgical object; and an interface seal defining an outer sealsegment and an inner seal segment extending at least radially inwardlyfrom the outer seal segment and with respect to the central longitudinalaxis of the seal housing, the inner seal segment defining a passagewhich at least partially accommodates the seal mount, the inner sealsegment in contacting relation with the seal mount adjacent the passageand dimensioned and adapted to establish and maintain a substantialsealed relation with the seal mount during angular movement thereof; anda sleeve extending from the seal housing, the sleeve dimensioned andadapted for passage through body tissue to provide access to anunderlying tissue site.
 2. The surgical access device according to claim1 wherein the inner seal segment of the interface defines an opening,the opening being a passage.
 3. The surgical access device according toclaim 1 wherein the inner seal segment is dimensioned to extend alongthe central longitudinal axis.
 4. The surgical access device accordingto claim 1 wherein the interface seal includes a relatively rigidinterface mount, the interface seal being mounted to the interfacemount.
 5. The surgical access device according to claim 4 wherein theinterface seal includes an annular gasket seal member mounted to theinterface mount and positioned to contact an internal surface of theseal housing in substantial sealing relation therewith to form asubstantial seal within the seal housing.
 6. The surgical access deviceaccording to claim 5 wherein the interface seal member and the gasketseal member are monolithically formed.
 7. The surgical access deviceaccording to claim 1 wherein the seal member of the seal mount includesa resilient member and a protective layer juxtaposed relative to theresilient member.
 8. The surgical access device according to claim 7wherein the protective layer comprises a fabric material.
 9. Thesurgical access device according to claim 1 wherein the seal mount isadapted to rotate about the central longitudinal axis.
 10. The surgicalaccess device according to claim 1 including a closure valve dimensionedand adapted to permit passage of the surgical object, and beingdimensioned and adapted to be substantially closed in the absence of thesurgical object.
 11. The surgical access device according to claim 1wherein the seal mount is detached from the inner seal segment of theseal interface whereby the seal mount is adapted to move relative to theinner seal segment during the angular movement thereof.